Brief summary

BA9™ is a Biosensors proprietary drug. The enhanced lipophilicity should make the BA9™ drug particularly well suited for short-term local delivery from an expanded vascular (coronary) balloon into adjacent vascular tissue. Following successful animal experiments, the conduct of a first clinical study is the next logical step in the development of the BA9™ drug coated balloon (BA9-DCB).

The study REFORM is, therefore, a first-in-man study. The study will seek to prove that the Biolimus A9-Drug Coated Balloon (BA9-DCB) is non-inferior to the approved CE marked Sequent Please-DCB with respect to % Diameter Stenosis (%DS) and has similar safety characteristics.

The study REFORM will include patients with coronary artery disease who have an indication for interventional treatment of in-stent restenosis (ISR) in a bare-metal stent (BMS) or drug-eluting stent (DES).  Patients will be followed up with clinic or phone visit at 1 month, 6 months, 12 and 24 months.

The study uses a prospective, multi-center, single blind, randomized controlled design to enroll up to 201 patients. Patients who meet all the eligibility criteria will be randomized 2:1 to receive treatment with either a BA9-DCB or a Sequent Please-DCB, respectively.

Primary endpoints

The primary endpoint is % of Diameter Stenosis of the target segment assessed by Quantitative Coronary Analysis (QCA) at 6 months.

Patients will undergo planned control angiogram after 6 months to assess the angiographic primary endpoint.

CERC Services

• • Project Management
  • Regulatory Submissions
  • Contract Management
  • Monitoring
  • SAE reporting/Meddra Coding
  • Data Management / EDC
  • Organisation of CEC
  • Organisation of DSMB
  • Corelab (QCA, Events)

Countries

6 countries : UK, Ireland, Spain, Italy, Germany and South Korea

Centers number

Total : 30 sites

UK : 8 sites

Ireland : 3 sites

Spain : 3 sites

Italy : 3 sites

Germany : 3 sites

South Korea : 10 sites